Molecular Insight Pharmaceuticals, Inc. (fka MIPIQ)

[surf1944]

http://data.cnbc.com/quotes/MIPI/tab/8

[TheFinalCD]

Now thats good New$$$$$$$

Surf

Why do you think they PR'd 4:01 instead of PM this morn?



http://ih.advfn.com/p.php?pid=nmona&article=42345655&symbol=MIPI

[surf1944]

Molecular Insight Pharmaceuticals' Onalta Phase 2 Data Published in Journal of Clinical Oncology
Date : 04/12/2010 @ 4:01PM
Source : MarketWire
Stock : Molecular Insight Pharmaceuticals, Inc. (MIPI)
Quote : 4.15 2.65 (176.67%) @ 7:22AM


Molecular Insight Pharmaceuticals' Onalta Phase 2 Data Published in Journal of Clinical Oncology

CAMBRIDGE, MA -- (Marketwire)
04/12/10
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced results from a completed Phase 2 clinical trial of Onalta? (Yttrium-90 edotreotide) have been published in the Journal of Clinical Oncology (JCO). Results from the Phase 2 clinical trial of 90 patients show that treatment with Onalta improved symptoms associated with metastatic carcinoid tumors.

Patients enrolled in the Phase 2 clinical study suffered from malignant metastatic carcinoid tumors (neuroendocrine tumors of the GI tract and bronchus) and were refractory to conventional treatment with the somatostatin analogue, octreotide. Y-90-edotreotide therapy resulted in objective tumor response or stable disease in 67 (74.4%) of 90 patients with metastatic carcinoid refractory to octreotide therapy. Median progression-free survival and overall survival were 16.3 and 26.9 months, respectively. Furthermore, there appeared to be a correlation with prolongation of the period of progression free survival in those patients who had durable diarrhea improvement (P =.031).

Key improvements in patient symptoms and quality of life related to carcinoid tumors were also noted. Symptoms of patients with carcinoid tumors include severe diarrhea, hot flushes and abdominal pain, among others. Among symptomatic patients, a trend toward improvement for each specified symptom was consistently demonstrated and statistically significant across all symptoms. Quality of life included assessments of anxiety, depression, pain and discomfort, among others. In addition, treatment was well-tolerated and had an acceptable adverse event profile.

David L. Bushnell, Jr., M.D., Professor of Radiology, University of Iowa and Chief, Diagnostic Imaging / Radioisotope Therapy, Iowa City VA Medical Center, led the study. In summarizing the study, he said: "90Y-edotreotide treatment was well-tolerated with an acceptable expected adverse effect profile. It's clear from this study that symptoms associated with malignant carcinoid tumors improve following this therapy among patients with no treatment alternatives. Furthermore, there was evidence of improved survival in a subpopulation of patients in this study."

"The patients in this study had incurable, progressive disease refractory to octreotide with severe symptoms which could themselves be life-threatening. In addition to nearly 75% of the patients showing disease stabilization, most tumor associated symptoms showed improvement with that improvement being of a sustained duration," said Norman LaFrance, M.D., Senior Vice President, Chief Medical Officer of Molecular Insight and an author on the JCO paper. "These findings further support Onalta's potential to improve outcomes among a refractory, metastatic patient population lacking treatment options."

The single-arm, multicenter Phase 2 study was conducted in 90 patients at 18 sites in the U.S. and Europe. The primary objective of the study was to evaluate the efficacy of Onalta in relieving symptoms in patients with malignant carcinoid tumors. Quality of life, objective tumor response and other safety and efficacy outcomes were assessed as secondary endpoints. Study treatment consisted of three cycles of 4.4 GBq (120 mCi) 90Y-edotreotide each, once every six weeks.

Nine (10%) of the patients discontinued treatment because of adverse events, five due to GI events. Twelve (13.3%) of the patients experienced adverse events that required a dosage adjustment or interruption of study drug treatment. The majority of adverse events (76 patients; 84.4%) were of a GI nature, with nausea, vomiting and diarrhea most frequently reported. Nausea, vomiting and abdominal pain were typically associated with amino acid infusion concomitant with therapy and these symptoms almost always subsided with cessation of amino acid infusion. Grade 3 to 4 adverse events were reported in 54 (60%) patients with lymphopenia, nausea and vomiting most frequently observed, while 3 (3.3%) patients experienced grade 3 to 4 renal or urinary toxicity of grade 3 oliguria, grade 3 dysuria, and grade 4 renal failure that lasted 6, 42, and 6 days respectively.

The Phase 2 clinical trial results were published in the April 1, 2010 print edition of the American Society of Clinical Oncology's Journal of Clinical Oncology in a paper titled: 90Y-Edotreotide for Metastatic Carcinoid Refractory to Octreotide. The article is also available online at http://jco.ascopubs.org/cgi/content/abstract/28/10/1652.

[zabone]

That would have been wise

[$Money Bags$]

Never mind, bailed at 4.67. Will be watching for reentry.

[$Money Bags$]

WOW, a friend put me on this for the afternoon so I bought 200 after hours at 2.36. This is unreal, I'm about to sell it. Amazing stock run!

I have my finger on the trigger, it just won't stop, any idea where it might land?

[surf1944]

4:07PM Molecular Insight Pharmas' Onalta phase 2 data published in Journal of Clinical Oncology (MIPI) 1.97 +0.46 : Co announces results from a completed Phase 2 clinical trial of Onalta (Yttrium-90 edotreotide) have been published in the Journal of Clinical Oncology. Results from the Phase 2 clinical trial of 90 patients show that treatment with Onalta improved symptoms associated with metastatic carcinoid tumors. Patients enrolled in the Phase 2 clinical study suffered from malignant metastatic carcinoid tumors and were refractory to conventional treatment with the somatostatin analogue, octreotide. Y-90-edotreotide therapy resulted in objective tumor response or stable disease in 67 (74.4%) of 90 patients with metastatic carcinoid refractory to octreotide therapy. Median progression-free survival and overall survival were 16.3 and 26.9 months, respectively. Furthermore, there appeared to be a correlation with prolongation of the period of progression free survival in those patients who had durable diarrhea improvement.

[invest2win]

Wow up to 2.85 after hours. I'm sure glad I didn't give up on this one with all my bitc.... Made a nice profit!

[invest2win]

Molecular Insight Pharmaceuticals, Inc. to Report Fourth Quarter and Year-End 2009 Financial and Operational Results Today

http://finance.yahoo.com/news/Molecular-Insight-iw-3805960818.html?x=0&.v=1

[invest2win]

Timber!!!!!!!!!!!!!!!! I hope the bleeding stops on Monday!

[invest2win]

This stock still sucks! WTF! Maybe I should short it instead

[invest2win]

This stock stinks!

[surf1944]

Yesterday's bounce was more than likely an oversold bounce off of another 52 week low in the stock price..............

[alien42]

MIPI up 47% on record volume

no PRs, a form 5 filing for the former CFO, not sure what's up here.

[surf1944]

Molecular Insight Pharmaceuticals Finalizes Onalta(TM) Manufacturing and Supply Agreements
Press Release
Source: Molecular Insight Pharmaceuticals, Inc.
On 8:30 am EDT, Wednesday October 21, 2009
Companies:Molecular Insight Pharmaceuticals, Inc.
CAMBRIDGE, MA--(Marketwire - 10/21/09) - Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI - News) today announced that it has executed an exclusive 10-year agreement to supply the Onalta(TM) 90-Y edotreotide radiotherapeutic to BioMedica Life Sciences S.A., Athens, Greece.

In September, Molecular Insight entered into a Territory License Agreement ("The Agreement") with BioMedica for commercialization of Onalta in certain European countries, the Middle East, North Africa, Russia and Turkey. Under the Agreement, BioMedica is expected to perform clinical studies and to secure all regulatory approvals to market, sell and distribute Onalta within its licensed territories. Molecular Insight retains Onalta rights in all other markets and territories, including the United States, Japan and Asia.

Molecular Insight also announced that it has entered into a contract manufacturing agreement with Berlin-based Eckert & Ziegler to manufacture and supply Onalta for compassionate use and registration clinical trials within the BioMedica territories. Upon European Medicines Agency (EMEA) approval of a Market Authorization Application, based on clinical studies, Eckert & Ziegler is expected to manufacture Onalta for commercial sales as well. The term of this agreement is for 10 years.

Onalta is a novel radiotherapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy. The EMEA has reviewed and accepted Onalta's Phase 3 clinical trial protocol design and has granted Onalta Orphan Drug Designation.

About BioMedica Life Sciences S.A.

BioMedica Life Sciences is a growing European biopharmaceutical company, based in Athens, Greece, that develops, markets and distributes a diversified portfolio of radiopharmaceutical, specialized therapeutic and diagnostic products and services. The company is the leading regional marketer and distributor of radiopharmaceuticals in South Eastern Europe, with growth plans to expand into the major markets of Europe. The company has invested in research and development programs, which have resulted in a promising portfolio of novel diagnostic and radiopharmaceutical products that are advancing into clinical development. The company's lead development product, Demogastrin� is a novel molecular imaging product that has secured European Regulatory Approval to start clinical development. BioMedica collaborates with the leading Greek universities and maintains strategic alliances with the country's most significant research centers. For more information on BioMedica Life Sciences, please visit http://www.biomedica.gr.

About Eckert & Ziegler

Eckert & Ziegler Strahlen- und Medizintechnik AG is a global isotope technology company and the holding company for a number of specialized subsidiaries in the fields of processing of radioisotopes and development, production, and marketing of isotope technology components, medical devices, and similar products. The group is one of the largest suppliers of radioactive components for radiation therapy and nuclear medicine, employing 520 employees worldwide. For more information on Eckert & Ziegler, please visit http://www.ezag.com/

[surf1944]

Molecular Insight Pharmaceuticals Presents Azedra(TM) 12-Month Efficacy Data From Phase I Clinical Trial in Neuroendocrine Tumors
Press Release
Source: Molecular Insight Pharmaceuticals, Inc.
On Monday October 5, 2009, 8:34 am EDT
Companies:Molecular Insight Pharmaceuticals, Inc.
CAMBRIDGE, MA--(Marketwire - 10/05/09) - Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI - News) today reported one-year follow-up data from a Phase I dose-escalation clinical study of Azedra(TM) demonstrating a positive safety profile and durable objective tumor responses in patients with neuroendocrine cancers, pheochromocytoma and paraganglioma. The study was designed to evaluate the safety and identify the maximum tolerated dose (MTD) of Azedra, as well as to collect clinical data on efficacy. These data were presented on October 2, 2009, at the North American Neuroendocrine Tumor Society (NANETS) 2009 Neuroendocrine Tumor Symposium in Charlotte, North Carolina. Azedra (Ultratrace� iobenguane I 131) is Molecular Insight's lead oncology targeted radiotherapeutic using the Company's proprietary radiolabeling technology platform.

In 12-month data reported today, a single dose of Azedra was shown to be well tolerated by patients, and toxicities were predictable and manageable. Additionally, Azedra demonstrated clinical benefit, stabilizing or reducing tumor volumes in a majority of patients. Twenty-one patients were treated at escalating dose levels from 6 to 9 mCi/kg. Objective tumor response according to Response Criteria in Solid Tumors (RECIST) was obtained every three months. Best confirmed overall response per RECIST was partial response (PR) for three patients (14%), stable disease for 14 (67%), progressive disease for two (10%), and not evaluable for two (10%) who had no follow-up scans. All three patients with PR demonstrated this response at the first post-therapy visit at three months and sustained the response through 12 months.

"Currently, there are no approved treatments in the United States for patients with metastatic neuroendocrine tumors, so a targeted radiotherapeutic such as Azedra that could provide a more potent, effective therapy would be a significant therapeutic advancement," commented R. Edward Coleman, M.D., of Duke University Medical Center, an author and investigator on the study. "These results at one year after therapy demonstrate that Azedra therapy may potentially benefit many patients who have metastatic pheochromocytoma or paraganglioma."

Data reported today provide long-term confirmation of preliminary Phase I clinical findings presented at the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting. In June 2009, Molecular Insight Pharmaceuticals initiated a single-arm, pivotal Phase 2 clinical trial for Azedra for the treatment of malignant pheochromocytoma under a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration (FDA). In addition, Azedra has been granted Orphan Drug designation and Fast Track status by the FDA. Under these programs, Molecular Insight plans to file a New Drug Application (NDA) based on the Phase 2 data and anticipates expedited FDA review of its application.

Phase I Study Overview

The Phase I dose-escalation study was designed to identify the maximum tolerated dose (MTD) of Azedra and to evaluate the safety and efficacy in patients with pheochromocytoma/ paraganglioma. The study results reported today support a maximum tolerated dose of 8 mCi/kg (maximum 600 mCi). Related adverse events were primarily hematologic or gastrointestinal, as expected.

Patient evaluations were scheduled at 3, 6, 9, and 12 months. Long-term follow-up will continue every six months through 5 years after treatment with Azedra. In addition to RECIST criteria, other efficacy evaluations included tumor biomarker response. Hypertension measurement was performed as part of safety evaluations and anti-hypertensive medication taper, discontinuation or changes were not a pre-specified endpoint in this study. Since hypertension typically occurs in more than 90 percent of pheochromocytoma/paraganglioma patients, changes in anti-hypertensive medication from baseline use, as a measure of clinical benefit and tumor response, were also evaluated.

While tumor markers in these patients are known to show frequent and considerable variability in values, many patients with elevated baseline tumor markers showed decreases, with many having normalization of these levels at a post-therapy visit that was consistent with preliminary findings reported previously [ASCO, 2008]. For example, at six months post-therapy, vanillylmandelic acid levels were normalized or decreased by at least 50% for four of the 11 evaluable patients with elevated baseline values. Furthermore, five of 15 (33%) patients on anti-hypertensive medications at time of therapy reduced or discontinued use of these medications following treatment.

Significant side effects observed in the trial were thrombocytopenia, neutropenia, dry mouth, salivary gland pain, nausea, vomiting, fatigue and anorexia. The dose-limiting toxicities were neutropenia (2), febrile neutropenia (1), and thrombocytopenia (1). Two patients died within the 12-month efficacy follow-up (hepatic failure, pulmonary embolism), while three died during long-term follow-up; all deaths were considered by the study investigator to be unrelated to Azedra. In this study, the drug demonstrated favorable dosimetry and a predictable safety profile at all doses tested. Per protocol, 8 mCi/kg (maximum 600 mCi) was confirmed as a tolerable dose in adult patients with pheochromocytoma.

For the study abstract, please visit the Company's website: http://www.molecularinsight.com/MolecularMedicine/ScientificPosters.aspx

[surf1944]

Molecular Insight Pharmaceuticals, Inc. Announces First Quarter 2008 Financial Results
Wednesday May 14, 8:30 am ET
- Conference Call Today at 10:00 a.m. Eastern Time -
- Zemiva(TM) Planned Pivotal Phase 2 Trial on Track While Oncology Portfolio Also Advances -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI - News) announced today financial results for the quarter ended March 31, 2008 and reiterated its clinical guidance for fiscal year 2008.

“During the first quarter, Molecular Insight continued to execute on our strategy to improve the detection and treatment of serious diseases through the use of targeted molecular radiotherapeutics and molecular imaging pharmaceuticals,” said David S. Barlow, Chairman and CEO of Molecular Insight. “We continue to progress our planned pivotal registration trial with Zemiva, our lead molecular imaging pharmaceutical candidate, to improve the detection and management of heart disease in the emergency department setting. We anticipate completing enrollment of this study in mid-2008, with results expected by year-end. Our portfolio of oncology molecular imaging and targeted radiotherapeutics also advanced, as we were pleased to announce the initiation of a Phase 2a trial of Azedra™, our targeted radiotherapeutic for neuroendocrine tumors, in children with neuroblastoma. Azedra is also nearing completion of a Phase 1 study in adult patients with pheochromocytoma and we intend to initiate the Phase 2 pheochromocytoma trial in the second half of the year as planned. We plan to initiate our Phase 1 dosimetry clinical program with Trofex™ for the detection, staging and monitoring of prostate cancer on schedule in the weeks ahead.”

Molecular Insight Clinical Guidance through 2008

Molecular Insight expects to meet the following clinical milestones in 2008:

* Complete Zemiva’s planned pivotal registration Phase 2 trial enrollment.
* Report Zemiva’s planned registration Phase 2 trial results.
* Complete Azedra’s Phase 1 dose-ranging clinical trial in pheochromocytoma.
* Initiate Azedra’s planned Phase 2 pivotal trial in pheochromocytoma.
* Initiate Trofex’s Phase 1 dosimetry trial for diagnosis of prostate cancer.
* Complete Trofex’s dosimetry trial.
* Initiate Trofex’s dose and image optimization trial.
* Initiate Onalta™’s Phase 1 dosimetry trial for the treatment of neuroendocrine tumors.
* Initiate Solazed™’s Phase 1 dosimetry trial in malignant melanoma.

Financial Highlights of the First Quarter 2008
http://biz.yahoo.com/bw/080514/20080514005404.html?.v=1

[surf1944]

Molecular Insight Pharmaceuticals, Inc. Presents Preclinical TrofexTM Prostate Cancer Data at AACR
Thursday October 25, 8:30 am ET
- Company's Prostate Cancer Detection Program Moving Towards Exploratory Human Studies -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI - News) today announced the presentation of preclinical data from its Trofex development program for two promising molecular imaging pharmaceutical candidates, MIP-1072 and MIP-1095, for potential use in the detection and monitoring of prostate cancer. Both compounds are radiolabeled small molecules that target prostate-specific membrane antigen (PSMA), a protein that is highly expressed by prostate tumor cells. Based on these and other studies, Molecular Insight plans to begin exploratory clinical trials in the first half of 2008 with both compounds to select a candidate for further clinical development and commercialization.

The studies were presented on October 24th in a poster session at the annual “Molecular Targets and Cancer Therapeutics” meeting in San Francisco, California, which was organized by the American Association for Cancer Research, National Cancer Institute, and European Organization for Research and Treatment of Cancer (AACR-NCI-EORTC).

“Prostate cancer is the second leading cause of cancer-related deaths in men in the United States and there is an urgent need for improved methods to diagnose, monitor and stage the disease, particularly for patients with metastatic disease,” said Martin G. Pomper, M.D., Ph.D., Professor, Departments of Radiology, Pharmacology and Oncology at Johns Hopkins University School of Medicine and an author on the study. “The ability to use targeted molecular imaging to clearly and specifically identify areas of metastatic prostate cancer in all areas of the body, including bone, would be a tremendous benefit to ensuring that patients receive proper treatment and staging of their disease.”

“These data underscore the potential of our innovative technologies and small molecule approach for targeted molecular imaging,” said John W. Babich, President and CSO of Molecular Insight and an author on the study. “PSMA represents an excellent target for prostate cancer detection. By targeting cancer using small molecules rather than antibodies, we can design tumor-targeting compounds with enhanced capacity for tumor uptake and faster blood clearance, while minimizing impact on non-cancer tissues. The study demonstrated that our Trofex program’s lead candidates, MIP-1072 and MIP-1095, both have high affinity and specificity for PSMA. Both compounds are internalized by PSMA-expressing cells in vitro and display excellent tumor to normal tissue ratios in vivo, which enables high quality imaging of prostate tumors.”

Dr. Babich noted that MIP-1072 and MIP-1095 were internally discovered by Molecular Insight. “The Trofex prostate cancer program has moved from concept to designation as development candidates in less than two years,” said Dr. Babich. ”Our next step will be to file an exploratory Investigational New Drug (IND) application for Trofex with the U.S. Food and Drug Administration to evaluate both candidate compounds in humans and determine which may be the most suitable for further clinical development in determining the localization of metastatic prostate cancer. We plan to begin a Phase 1 dosimetry study under the exploratory IND process in the first half of 2008.”

Prostate cancer is the most frequently diagnosed cancer in men in the United States, with 218,000 new cases per year. It is the second leading cause of cancer deaths in men. There is a major unmet need for accurate, rapid and non-invasive diagnostic tools to determine whether the cancer has spread beyond the prostate to other parts of the body and to help guide treatment. Current techniques often do not confirm the presence of cancer in these patients and the tumors may go undetected.

Study Details

MIP-1072 and MIP-1095 are novel 123I-labeled glutamate-urea-lysine analogs which, in laboratory studies, exhibit high affinity binding to PSMA on cancer cells with Kd values of 3.0 and 0.6 nM, respectively. Both compounds are internalized by PSMA-expressing cells in vitro, which should afford enhanced tumor to background discrimination. In xenograft models, MIP-1072 and MIP-1095 achieved peak uptake of 17% and 34% of the injected dose/gram tumor, respectively, resulting in a tumor to blood ratio of >30 to 1 and a tumor to muscle ratio of >60 to 1. Specificity of the compounds was demonstrated by co-injection with a structurally unrelated inhibitor of PSMA, which reduced tumor uptake by more than 30-fold. SPECT/CT imaging confirmed localization of MIP-1072 to PSMA-expressing tumors but not to tumors lacking PSMA.

The poster, entitled, “Design and Evaluation of Novel Glutamate-Urea Heterodimers That Target PSMA as Molecular Imaging Agents for Prostate Cancer,” was presented by Shawn M. Hillier, Ph.D., of Molecular Insight Pharmaceuticals. Co-authors include Kevin P. Maresca, Ph.D.; Frank J. Femia, Ph.D.; Chris Barone; Craig N. Zimmerman, Ph.D.; John L. Joyal, Ph.D.; and John W. Babich, Ph.D., from Molecular Insight Pharmaceuticals, Inc.; and Martin G. Pomper, M.D., Ph.D., and Catherine A. Foss, Ph.D., from Johns Hopkins University.

About Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals (NASDAQ: MIPI - News) is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve healthcare for patients with life-threatening diseases. The company is focused on discovering, developing and commercializing innovative and molecular radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Its lead molecular radiotherapeutic product candidates, Azedra and Onalta, are being developed for detection and treatment of cancer. The company’s lead molecular imaging pharmaceutical product candidate, Zemiva, is being developed for the diagnosis of cardiac ischemia, or insufficient blood flow to the heart. In addition, the company has a growing pipeline of product candidates resulting from application of its proprietary platform technologies to new and existing compounds. Molecular Insight Pharmaceuticals is based in Cambridge, Massachusetts and its website address is: www.molecularinsight.com.

[surf1944]

Press Release Source: Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals, Inc. Announces Positive Results of Azedra(TM) Phase 1 Dosimetry Trial for Neuroendocrine Tumors
Thursday October 18, 7:00 am ET
- Ultratrace Technology Demonstrated Increased Efficacy and Improved Side Effect Profile in Data Presented at European Association of Nuclear Medicine Meeting -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI - News) announced today positive results of the Phase 1 dosimetry trial of its lead oncology molecular radiotherapeutic candidate, AzedraTM (UltratraceTM iobenguane I 131, or Ultratrace MIBG) and further preclinical studies. The trial was designed to evaluate the safety, tolerability and distribution of Azedra in adult patients with either carcinoid or pheochromocytoma neuroendocrine cancers. Results from the trial were part of an oral presentation at the European Association of Nuclear Medicine 2007 Annual Congress in Copenhagen, Denmark. The presentation also highlighted that the ultrapurity resulting from Ultratrace technology used in Azedra produced no change in overall patient safety and that Azedra demonstrated increased efficacy and safety over currently available MIBG in preclinical animal models.

Azedra has Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. Developed using Molecular Insight’s proprietary Ultratrace technology, Azedra, which is free of unnecessary cold contaminants, is designed to maximize the radiotherapy delivered to neuroendocrine tumors while minimizing side effects. Cold contaminants are biologically active, non-radiolabeled MIBG molecules present in currently available MIBG therapy that, when administered to patients, may sub-optimize efficacy and cause unnecessary side effects.

“Azedra exemplifies Molecular Insight’s strategy to apply its radiochemistry expertise to improve an existing therapy. Current targeted radiotherapies for cancer suffer from sub-optimal radiochemistry, which leads to an excess of non-therapeutic, cold contaminant molecules administered to patients. These cold contaminants compete for tumor binding and reduce the amount of therapeutic radiopharmaceutical that can bind the cancer cells. Our proprietary Ultratrace technology eliminates the presence of cold contaminants, creating a product that contains only radiolabeled molecules,” said John W. Babich, President and CSO of Molecular Insight and an author on the study. “We believe that this ultrapurity, or lack of cold contaminants, produces optimal tumor uptake and efficacy. Additionally, the animal data in this study demonstrated that Azedra’s ultrapurity resulted in a more favorable cardiovascular side effect profile than is available with current MIBG.”

“There are no currently approved treatments in the United States for patients with metastatic neuroendocrine tumors, so a targeted radiotherapeutic such as Azedra that might provide a more potent, effective therapy would be a significant therapeutic advancement for the treatment of these diseases,” commented Dr. R. Edward Coleman of Duke University Medical Center and an author on the study.

Dr. Norman LaFrance, Senior Vice President of Clinical Development and CMO of Molecular Insight added, “As we anticipated and demonstrated in this dosimetry trial, Ultratrace technology did not alter the tissue distribution or pharmacokinetics of Azedra in neuroendocrine tumor patients with pheochromocytoma or carcinoid, enabling us to progress the product into the therapeutic dose-ranging trial that is currently underway. We are very pleased that the current trial is confirming that Azedra is well tolerated with impressive preliminary efficacy, and we expect that after we determine the maximum tolerated dose for Azedra, we will initiate a planned pivotal Phase 2 efficacy trial in the first half of 2008.”

Study Design and Outcomes

The study, “Radiation Dosimetry and Clearance of No Carrier-added 131I-MIBG (Ultratrace) in Seven Carcinoid and Four Pheochromocytoma Patients,” was designed to evaluate Ultratrace technology and its application in cancer therapy, the impact of cold-carrier MIBG on efficacy and toxicity and the Phase 1 dosimetry of Azedra, which was designed to evaluate the safety, tolerability and distribution of Azedra in adult patients with one of two forms of neuroendocrine cancer, carcinoid or pheochromocytoma. Overall, Azedra was well tolerated and the pharmacodynamics observed were consistent with results previously observed with cold-carrier 131I-MIBG.

In the dosimetry study, seven patients with carcinoid disease and four patients with pheochromocytoma received a single intravenous administration of Azedra. Patients were then scanned with serial anterior/posterior scintigraphic images, and blood and urine samples were collected during a five day follow-up period. Analysis of the scans in the region of interest analysis was then used to compute radioactive uptake for several organs. Distribution of the radioisotopes was as expected in internal organs. From a pharmacokinetic standpoint, Azedra blood levels rapidly declined after i.v. injection.

Authors on the study were: J.A. Barrett, N. Borys, J.F. Kronauge, H. Mok, J. Qi and J.W. Babich, from Molecular Insight Pharmaceuticals, Inc.; R.E. Coleman, M.A. Morse, N. Petry and G. Vaidyanathan, from Duke University; and J.B. Stubbs, from Radiation Dosimetry Systems, Inc.

[iOwnSomeBio]

Molecular Insight Pharmaceuticals, Inc. Announces Initial Public Offeringadvertisement

Molecular Insight Pharmaceuticals, Inc. announced today the pricing of its initial public offering of 5.0 million shares of common stock at a price of $14.00 per share. All of the shares are being sold by Molecular Insight. Molecular Insight's common stock will trade on the Nasdaq Global Market under the trading symbol "MIPI."

RBC Capital Markets Corporation and Jefferies & Company, Inc. are acting as joint book-running managers. A.G. Edwards & Sons, Inc. and Oppenheimer & Co. Inc. are acting as co-managers for the offering. Molecular Insight has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares to cover over-allotments, if any.

This offering will be made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from the offices of RBC Capital Markets Corporation, One Liberty Plaza, 165 Broadway, New York, NY 10006 and Jefferies & Company, Inc., 520 Madison Ave., New York, NY 10022.

A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission on February 1, 2007. This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction where such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Molecular Insight Pharmaceuticals, Inc.

Molecular Insight Pharmaceuticals is a biopharmaceutical company specializing in the emerging field of molecular medicine, applying innovations in the identification and targeting of disease at the molecular level to improve patient healthcare by addressing significant unmet needs. The company is focused on discovering, developing and commercializing innovative and targeted radiotherapeutics and molecular imaging pharmaceuticals with initial applications in the areas of oncology and cardiology. Molecular Insight's lead radiotherapeutic product candidates, Azedra and Onalta, are under development for the treatment of cancer. The company's lead molecular imaging pharmaceutical product candidate, Zemiva, is under development for the diagnosis of cardiac ischemia, or insufficient blood flow to the heart. In addition, the company has a growing pipeline of product candidates resulting from application of its proprietary platform technologies to new and existing compounds. Molecular Insight Pharmaceuticals, Inc. is based in Cambridge, Massachusetts. Contact Information: Molecular Insight Pharmaceuticals, Inc. Priscilla Harlan, 617-492-5554 Vice President, Corporate Communications

Copyright 2007 BusinessWire

http://news.moneycentral.msn.com/ticker/article.aspx?Feed=BW&Date=20070202&ID=6429377&Sy....